K904128 is an FDA 510(k) clearance for the PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER. This device is classified as a Positioner, Tooth, Preformed (Class I - General Controls, product code KMY).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on November 9, 1990, 65 days after receiving the submission on September 5, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.
| 510(k) Number | K904128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1990 |
| Decision Date | November 09, 1990 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KMY — Positioner, Tooth, Preformed |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5525 |